Vital Signs™ AMN520X4F (UDI 10190752122987)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10190752122987), received between Mar 9, 2021 and Jun 10, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2021Material Puncture/Hole; Material Puncture/Hole

  THE CUSTOMER REPORTED SEVERAL ISSUES WITH THE AMN520X4F LIMB--O¿ SINGLE LIMB ANESTHESIA BREATHING CIRCUIT "FAILING" WHILE IN A PROCEDURE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11980122 ↗
• InjuryMar 9, 2021Leak/Splash; Leak/Splash

  THE CUSTOMER REPORTED AN INCIDENT ONE MONTH AGO WITH AMN520X4F LIMB--O" SINGLE LIMB ANESTHESIA BREATHING CIRCUIT. THREE OR FOUR CIRCUITS DIDN'T PASS THE LEAK TEST WHILE DOING A MACHINE TEST. AND ONE CASE DURING OPERATION, THE ANESTHESIA MACHINE SHOWED A CIRCUIT LEAK IN THE MIDDLE OF A CASE AND THEY HAD TO BAG THE PATIENT BUT THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11449032 ↗